Angela Venegas

• Manage the process for emission/revision of Quality Management Systems (QMS) documents. Coordinate QMS training activities. Monitor KPIs on Training Management and Document Control • Be the subject matter expert for Quality Plans, Document Control, Record and Training Management • Lead Internal Projects for QMS • Co-Auditor of Internal and Supplier Audits. Lead Auditor certificate ISO 13485 and ISO 9001 • Support external audit preparation and interface, for Munich and France sites

• Manage the process for emission/revision of Quality Management System documents • Maintain database of internal QMS documents • Coordinate QMS training activities through set up of training roles • Be the subject matter expert for Document Control, Record and Training Management • Participate in process improvement effort • Support the process of Internal Audits Auditor certificate ISO 13485 • Support external audit preparation and interface, for Munich, Germany and Arras, France sites.

• Co-ordinated and documented root-cause investigations based on Post Launch Complaints. • Performed and documented Post Launch Risk Assessments (PLRA) as per ISO 14971:2007. Risk Specialist Certified. • Supported the creation of a team from 1 to 10 associates carrying out the mentoring of new team members on the complaint handling process. • As a member of a team of 10 associates I participated in the process improvement effort.

• Co-ordinated and documented root-cause investigations based on Post Launch Complaints • Supported the reportability process in case of occurrence of Adverse Events. • Carried out training activities related to the complaint process within the organization. • Performed Post Launch Risk Assessment (PLRA) as per ISO 14971:2007 to assess the safety and risks of the product to trigger further actions. • Controlled and monitored complaints KPIs.

• Searched and explored new and current platforms of construction tenders for future markets in Latin America. • Collected information from different construction projects to support the organization of the software development area. • Was required to write and publish news articles on trends within the construction industry.

• Supported in consulting of financial planning. • Collected and analyzed information related to financial planning. • Was required to develop and program financial planning application models to create forecast and reports using Hyperion Planning (Oracle).

• Supported the selection, evaluation and re-evaluation process of suppliers. • Performed investigations on the quality of raw materials. • Was required to identify, monitor and control claims to suppliers, Supplier Corrective Action Requests (SCAR). • Created trend reports.

Thesis Project: “Refine the knowledge reuse to improve the quality of the product development process”. Deal with different kind of methodologies for the product development process.

Economic analysis of business decisions, Management Accounting, Programming and Control Engineering Projects, Prediction Methods, Strategy Supply Networks, Strategic Direction of Innovation, Integrating technology solutions in Engineering Projects.

Design and implement systems of quality control and solutions to improve productivity. Manage the processes of technological development.